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ImClone, Bristol-Myers Squibb Seek FDA Approval Of Erbitux.(Brief Article)
2001 NOV 21 - (NewsRx.com & NewsRx.net) -- ImClone Systems, Inc., (IMCL) and Bristol-Myers Squibb Co. (BMY) have completed their rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for approval of Erbitux (formerly known as IMC-C225) for the treatment of irinotecan-refractory colorectal cancer.
Erbitux is an investigational monoclonal antibody designed to target and block the epidermal growth factor receptor (EGFR), which is expressed on the surface of certain cancer cells, including colon cancer. Bristol-Myers Squibb and ImClone Systems recently announced an agreement to codevelop and copromote Erbitux in the United States, Canada, and Japan.
In February 2001, the FDA granted ImClone Systems Fast Track designation for Erbitux in the treatment of irinotecan-refractory colorectal cancer. The Agency's ...
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...Feb. 1, 2001 ImClone Systems Incorporated...designated as Fast Track, its development...IMC-C225 is ImClone Systems' investigational...appropriate for Fast Track Designation...Executive Officer of ImClone Systems Incorporated...
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...Chief Executive Officer of ImClone Systems Incorporated. In February 2001, the FDA granted ImClone Systems Fast Track designation for ERBITUX...be reviewed under the Fast Track Program. ImClone Systems is studying ERBITUX in...
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...2001, the FDA granted ImClone Systems Fast Track designation for ERBITUX...to meet the criteria for Fast Track designation for an application...to be reviewed under the Fast Track Program. ImClone Systems is studying ERBITUX in...
- ImClone Systems Incorporated Announces Decision by The FDA Not To Accept For...
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...2001, the FDA granted ImClone Systems Fast Track designation for ERBITUX...to meet the criteria for Fast Track designation for an application...to be reviewed under the Fast Track Program. ImClone Systems is studying ERBITUX(TM...
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...the criteria for Fast Track designation, and...the FDA granted ImClone Systems a Fast Track designation for IMC...reviewed under the Fast Track Program. "The rolling...Operating Officer of ImClone Systems. "The advantage...
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- Press release article from: Business Wire March 26, 2001 700+ words
...Operating Officer of ImClone Systems. Earlier this year...Administration granted ImClone Systems a Fast Track designation for...reviewed under the Fast Track Program. According...type of cancer. ImClone Systems is studying IMC...
- Antibodies Derived from Dyax Library Enter Clinical Trials at ImClone Systems.
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...tumors. As reported by ImClone Systems, inhibition of the...preclinical models. ImClone Systems announced in a company...EU, and DX-88 has Fast Track designation in the...libraries to Dyax , ImClone Systems and other Dyax licensees...
Source: HighBeam Research, ImClone, Bristol-Myers Squibb Seek FDA Approval Of Erbitux.(Brief...